RESOURCES & gUIDANCE 

Guidance

The following guidance is from national and international regulators and life science organisations, to help researchers, clinical trial sponsors, clinical trial delivery teams and the wider community in navigating existing regulatory frameworks and best practice, with the aim of encouraging adoption and use of remote methods of trial delivery. 

General Guidance

• Recommendations for Decentralised Elements in Clinical Trials Published by the EMA

• Decentralized Clinical Trials for Drugs, Biological Products, and Devices: Guidance for Industry, Investigators, and Other Stakeholders Published by the FDA

• First set of recommendations for Remote decentralised clinical trials Published by Trials @ Home consortium

• Decentralizing Clinical Trials. A New Quality-by-Design, Risk-Based Framework Published by ACRO Health

• Decentralised clinical trials (DCTs) with medicinal products in Switzerland Published by SwisdMedic & SwissEthics

• The Danish Medicines Agency’s guidance on the implementation of decentralised elements in clinical trials with medicinal products Published by Laegemiddelstyrelsen Danish Medicines agency 

• Criteria for selection of appropriate trials Published by Trials @ Home consortium

• People-Centred Clinical Research Published by HRA 

• Learning from remote decentralised clinical trial experiences: A qualitative analysis of interviews with trial personnel, patient representatives and other stakeholders  Published by Trials@Home Consortium-

• A secondary qualitative analysis of stakeholder views about participant recruitment, retention, and adherence in decentralised clinical trials (DCTs) Published by Trials@Home Consortium

Enrolment and Consent: 

• Joint statement on seeking consent by electronic methods Published by MHRA/HRA

• Use of Electronic Informed Consent in Clinical Investigations - Questions and Answers Published by the FDA

• Using digital tools to enroll and retain diverse participants Published by the Digital Medicine Society

• eConsent Initiative Published by EFGCP

Quality Assurance: 

• Access to Electronic Health Records by Sponsor representatives in clinical trials Published by GOV.ac.uk

• MHRA-produced FAQs for monitoring Forum published by MHRA

Trial Delivery: 

• Modernizing Clinical Trial Conduct Published by TransCelerate Biopharma Inc

• Digital Health Technologies for Remote Data Acquisition in Clinical Investigations Published by FDA

• A systematic review of methods used to conduct decentralised clinical trials Published by Trials@Home Consortium

• Set-up of interventional research Published by HRA 

• PODCAST: Harnessing the power of digital technology in clinical trials (click on the link to download the audio transcript) Published by NIHR

• PODCAST: The power of virtual trials: overcoming geographical boundaries (click on the link to download the audio transcript) Published by NIHR

Outcome Measures:

• Developing novel digital endpoints in clinical trials Published by Clinical Trials Transformation Initiative

• Digital Health Technologies for Remote Data Acquisition in Clinical Investigations Published by the FDA

• Best Practices for Digital Health Outcomes Published by NINDS

• Library of Digital Endpoints Published by Digital Medicine Society (DiMe)

Supporting Digital Accessibility: 

• Assisted digital support: an introduction Published by GOV.co.uk 

• Accessibility and assisted digital Published by GOV.co.uk 

Case Studies & Examples 

The following are examples of remote methods that have been used effectively in clinical trial delivery and patient engagement.  We hope that by sharing people’s experiences we will encourage adoption and use of remote methods.

Using Electronic Health Records

• Using patients’ electronic health records to improve health and care Published by NIHR

Improving Patient Engagement

• Pushing virtual boundaries to improve patient engagement and accessibility Published by NIHR

• POWeR+ programme motivates people to engage with online weight management Published by NIHR

Facilitating Rapid Recruitment

• PANORAMIC: the fastest ever recruiting trial of its kind Published by NIHR

Providing Information

• Digital media for sexual health promotion Published by NIHR

Supporting Diagnosis

• Digital test provides quick and clear data for ADHD diagnosis Published by NIHR

Innovative Interventions

• Virtual reality for mental health Published by NIHR

• Internet-delivered guided self-help Acceptance and Commitment Therapy for family carers of people with dementia (IACT4CARERS: a qualitative study of carer views and acceptability Published by PubMed

Decentralised Trials 

• Advancing decentralised clinical trials: Patient Recruitment Centres cement their success Published by NIHR